BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEATCLOSE SUTURING DEVICE

    MDR report key: 2111654 · Received June 2, 2011

    Report

    Report Number
    3008581373-2011-00001
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 13, 2011
    Manufacturer
    NEATSTITCH LTD.
    Product Code
    GAM
    PMA / PMN Number
    K063462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEATCLOSE DEVICE INVOLVES TWO FDA REGISTERED MECHANISMS: THE CARTRIDGE (NEATCLOSE SUTURING DEVICE) CONTAINING THE SUTURE, PRODUCT CODE GAM, A SINGLE USE DEVICE. THE HANDLE (INSTRUMENT, LIGATURE PASSING AND KNOT TYING), PRODUCT CODE HCF, A REUSABLE DEVICE. SINCE THE REPORT CONCERNS AN ADVERSE EVENT RELATED TO THE NEEDLE, (SUSPECT MEDICAL DEVICE) WE REPORT THE SUTURING DEVICE AND NOT THE INSTRUMENT LIGATURE. AT THE END OF THE LAPAROSCOPIC PROCEDURES, THE CARTRIDGE CONTAINING THE NITINOL NEEDLES IS DISCARDED INTO A SPECIAL CONTAINER FOR INFECTED SHARP OBJECTS, THEREFORE IT WAS NOT RETURNED TO MANUFACTURER. CAUSE ANALYSIS: THE SURGEON HAS NOT BEEN IN-SERVICED BY THE REP ON THE OPERATION OF NEATCLOSE DEVICE AND HAD NEVER BEFORE USED THE DEVICE. IN THE DESCRIBED INCIDENT, SHE USED IT FOR THE FIRST TIME UNDER GUIDANCE OF THE ASSISTING SURGEON, WHILE THE NEATSTITCH REP WAS NOT PRESENT. THE HOSPITAL PROCEDURES DO NOT ALLOW SALES REPS TO BE PRESENT INSIDE THE OPERATING ROOM DURING THE ENTIRE OPERATION, AND THEY ARE SUPPOSED TO BE SUMMONED INTO THE ROOM PRIOR TO THE USE OF THE RELEVANT DEVICE. FOR SOME REASON, NEATSTITCH'S REP WAS NOT ALERTED INTO THE OPERATING ROOM, AND THE DEVICE WAS OPERATED IN HIS ABSENCE. IT IS NEATSTITCH'S CONCLUSION THAT THE DEVICE WAS USED ERRONEOUSLY AS WELL AS THE TROUBLE SHOOTING WAS NOT PERFORMED PROPERLY AS THE THREAD WAS PULLED FORCEFULLY INSTEAD OF SIMPLY RETRIEVING THE NEEDLE. CONCLUSION: INCIDENT CAUSE - USER ERROR.

    Description of Event or Problem · 1

    BACKGROUND: THE NEATCLOSE SUTURING DEVICE IS INTENDED FOR USE IN THE APPROXIMATION AND/OR LIGATION OF SOFT TISSUES IN LAPAROSCOPIC PROCEDURES. THE EVENT OCCURRED DURING A LAPAROSCOPIC HYSTERECTOMY PERFORMED AS PART OF NEATCLOSE EVALUATION PROCESS IN THE HOSPITAL. THE SURGEON USED THE DEVICE FOR THE FIRST TIME IN SURGERY AND WAS ASSISTED BY ANOTHER SURGEON WHO HAS USED THE NEATCLOSE ABOUT 5 TIMES DURING THE EVAL PROCESS FOLLOWING IN-SERVICE AND IN PRESENCE OF THE COMPANY REP. THE SURGEON HAS NOT BEEN IN-SERVICED PRIOR TO THE INITIAL USE OF THE DEVICE. THE REP THAT WAS IN CHARGE OF CONDUCTING THE ON-SITE IN-SERVICE DURING THE EVALUATION WAS ASKED TO WAIT OUTSIDE THE OPERATING ROOM TO BE CALLED IN DURING THE USE OF THE DEVICE. EVENTUALLY HE WAS NOT CALLED-IN WHEN THE DEVICE WAS USED, BUT ONLY AFTER THE NEATCLOSE WAS ACTIVATED AND THE EVENT TOOK PLACE. DESCRIPTION OF EVENT: BASED ON THE REPORTS RECEIVED AND THE TELEPHONE CONVERSATIONS WITH THE ASSISTING DR., IT APPEARS THAT THE SURGEON HAS TWISTED THE DEVICE'S HANDLE FOLLOWING ENGAGEMENT OF THE NEEDLE-GUIDES IN THE PERITONEUM, WHILE SEARCHING FOR THE HANDLE'S ACTIVATION BUTTON THAT WAS FACING THE OPPOSITE SIDE OF THE HANDLE (NOT FACING THE SURGEON). THE APPLICATION OF A TORQUE (TWIST) TO THE HANDLE ONCE ENGAGED AGAINST THE PERITONEUM, CAUSED ONE OF THE NEEDLE-GUIDES TO DEVIATE FROM THE DIRECTION OF THE NEEDLE TARGETS, THUS LEADING TO ONE OF THE TWO NEEDLES TO MISS, NOT BEING ABSORBED BACK INTO THE CARTRIDGE, THUS GETTING STUCK IN THE ABDOMINAL WALL (DIRECTED OUTWARDS THE BODY, TOWARDS THE DEVICE, AS THE NEATCLOSE NEEDLES ARE ALWAYS DIRECTED FROM THE INSIDE OUT UPON ACTIVATION OF THE DEVICE). THE USER ERROR OF TWISTING THE NEATCLOSE HANDLE FOLLOWING THE ENGAGEMENT OF THE NEEDLE-GUIDES IN THE TISSUE HAS LED TO A MISFIRE AND TO A NITINOL NEEDLE REMAINING IN THE PORT'S TRACK IN THE ABDOMINAL WALL. THE NEEDLE PROTRUDING INTO THE PORT WAS FELT UPON THE RE-INSERTION OF THE TROCAR INTO THE PORT. THE NEEDLE WAS ALSO FELT AND LOCALIZED BY THE SURGEON AND ASSISTANCE WHO INSERTED A FINGER INTO THE PORT. IN THIS STAGE, THE PGA THREADS THAT WERE OBSERVED OUT OF THE PORT WERE MISTAKENLY PULLED WITH THE INTENTION TO RETRIEVE THE NEEDLE OUT OF THE ABDOMEN WALL. THIS IN FACT CAUSED THE NEEDLE TO BE INSERTED BACKWARDS INTO THE SUBCUTANEOUS TISSUE, AS THE NEATCLOSE THREAD IS CONNECTED TO THE TIP OF THE NEEDLE (RATHER THAN THE TAIL). PULLING THE THREAD ALSO LED TO ITS TEAR AND DETACHMENT FROM THE NEEDLE. THE NEEDLE WAS EVENTUALLY LEFT IN THE SUBCUTANEOUS TISSUE OF THIS OBESE PT AND THE PROCEDURE COMPLETED. (FOR VISUAL ILLUSTRATION OF DEVICE OPERATION REFER TO VIDEO AND ANIMATION DEMONSTRATION AT HTTP://WWW.YOUTUBE.COM/WATCH?V=2MUA5W876LM.) FOLLOWING A CT GUIDED WIRE LOCALIZATION OF THE NEEDLE PERFORMED TWO DAYS AFTER SURGERY THE NEEDLE WAS LOCATED INSIDE THE ANTERIOR RECTUS MUSCLE SHEATH. THE NEEDLE LAID ALONG THE RECTUS MUSCLE ON TOP OF THE MUSCLE. THE PT WAS TAKEN TO THE OPERATING ROOM AND THE NEEDLE WAS RETRIEVED THROUGH A SMALL SKIN INCISION PERFORMED UNDER A LOCAL ANESTHESIA. THE PT SUFFERED NO FURTHER EFFECTS OR SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEATCLOSE SUTURING DEVICE NEATCLOSE PORT CLOSURE DEVICE GAM NEATSTITCH LTD. 11001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization